Thorax 1999;54:223-229 ( March )

One year prospective open study of the effect of high dose inhaled steroids, fluticasone propionate, and budesonide on bone markers and bone mineral density

J A Hughes,^a B G Conry,^a S M Male,^a R Eastell^b

^a Kent & Sussex Hospital, Tunbridge Wells, Kent TN4 8AT, UK, ^b Northern General Hospital, Sheffield S5 7AU, UK

Correspondence to: Dr J A Hughes.

Received 16 February 1998; Returned to authors 12 May 1998; Revised version received 10 November 1998; Accepted for publication 17 November 1998

BACKGROUNDInhaled corticosteroids are recognised as the most effective agents in the treatment of asthma. However, concerns have been expressed about the effects of high doses of inhaled corticosteroids on safety in relation to bone resorption and formation. This study measures the effects of two inhaled corticosteroids on bone markers and bone mineral density (BMD) over one year.
METHODSA one year randomised, prospective, open parallel study comparing inhaled fluticasone propionate (FP), 500 µg twice daily in 30 patients, and budesonide (BUD), 800 µg twice daily in 29 patients, delivered by metered dose inhaler and large volume spacers was performed in adults with moderate to severe asthma. Biochemical markers of bone turnover (osteocalcin, procollagen type 1 C-terminal propeptide (PICP), immunoreactive free deoxypyridinoline (iFDpd), N-terminal crosslinked telopeptides of type I collagen (NTx)), BMD at the spine and femoral neck, and serum cortisol concentrations were measured at baseline and 12 months later.
RESULTSThere were no significant differences between the inhaled steroids on bone markers of bone resorption and formation or bone mineral density. Bone mineral density of the spine increased slightly in both groups over the 12 month period. Serum osteocalcin levels increased from baseline in both treatment groups (FP 16.9%, p = 0.02; BUD 14.3%, p = 0.04). PICP did not differ significantly from baseline. Both markers of bone resorption (iFDpd, NTx) varied considerably with no significant changes after one year. There was a significant correlation in percentage change from baseline between BMD of the spine and osteocalcin at 12 months (r = 0.4, p = 0.017). Mean serum cortisol levels remained within the normal range in both groups following treatment.
CONCLUSIONThere was no evidence of a decrease in BMD during 12 months of treatment with high doses of either FP or BUD. The change in spine BMD correlated with the increase in osteocalcin. Studies extending over several years are needed to establish whether these findings persist.

Keywords: asthma; inhaled corticosteroids; fluticasone propionate; budesonide; bone markers; bone mineral density

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© 1999 by Thorax
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